Study of Aripiprazole in Patients With Acute Bipolar Mania

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder

The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

615

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria
        • Local Institution
      • Novi Iskar, Bulgaria
        • Local Institution
      • Pleven, Bulgaria
        • Local Institution
      • Sofia, Bulgaria
        • Local Institution
      • Varna, Bulgaria
        • Local Institution
  • Croatia
      • Osijek, Croatia
        • Local Institution
      • Rijeka, Croatia
        • Local Institution
      • Split, Croatia
        • Local Institution
      • Zagreb, Croatia
        • Local Institution
  • Mexico
      • Nuevo Leon, Mexico
        • Local Institution
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico
        • Local Institution
    • Jalisco
      • Zapopan, Jalisco, Mexico
        • Local Institution
    • Nuevo Leon
      • Col. Obispado, Nuevo Leon, Mexico
        • Local Institution
      • Monterrey, Nuevo Leon, Mexico
        • Local Institution
    • San Luis Potosi
      • Fracc. Industrias, San Luis Potosi, Mexico
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico
        • Local Institution
  • Peru
      • Lima, Peru
        • Local Institution
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Local Institution
      • Kazan, Russian Federation
        • Local Institution
      • Leningrad Region, Russian Federation
        • Local Institution
      • Moscow, Russian Federation
        • Local Institution
      • Nizhniy Novgorod, Russian Federation
        • Local Institution
      • Samara, Russian Federation
        • Local Institution
      • St. Petersburg, Russian Federation
        • Local Institution
      • Volgograd, Russian Federation
        • Local Institution
    • Lipetsk Region
      • Lipetsk, Lipetsk Region, Russian Federation
        • Local Institution
  • South Africa
    • Gauteng
      • Florida, Gauteng, South Africa
        • Local Institution
      • Pretoria, Gauteng, South Africa
        • Local Institution
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, South Africa
        • Local Institution
    • Kwa Zuluu Natal
      • Berea, Kwa Zuluu Natal, South Africa
        • Local Institution
  • United States
    • California
      • Anaheim, California, United States
        • Local Institution
      • Cerritos, California, United States
        • Local Institution
      • Garden Grove, California, United States
        • Local Institution
      • National City, California, United States
        • Local Institution
      • Pico Rivera, California, United States
        • Local Institution
      • Riverside, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States
        • Local Institution
    • Florida
      • Maitland, Florida, United States
        • Local Institution
      • Tampa, Florida, United States
        • Local Institution
    • Louisiana
      • Shreveport, Louisiana, United States
        • Local Institution
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Local Institution
    • Ohio
      • Cleveland, Ohio, United States
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Local Institution
    • Texas
      • Desoto, Texas, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
Drug: Aripiprazole
Tablets, oral, 15-30 mg, once daily, 12 weeks.
Other Names:
  • Abilify
Active Comparator: C
Drug: Haloperidol
Capsule, oral, 5-15 mg, once daily, 12 weeks.
Placebo Comparator: A
Drug: Placebo
Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in a mania rating scale at endpoint

Secondary Outcome Measures

Outcome Measure
Response rate and Clinical Global Impression scale at endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

November 19, 2004

First Submitted That Met QC Criteria

November 19, 2004

First Posted (Estimate)

November 22, 2004

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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